Implementing Pharmacogenomics in Europe: Design and Implementation Strategy of the Ubiquitous Pharmacogenomics Consortium.

Despite scientific and clinical advances in the field of pharmacogenomics (PGx), application into routine care remains limited. Opportunely, several implementation studies and programmes have been initiated over recent years. This article presents an overview of these studies and identifies current research gaps. Importantly, one such gap is the undetermined collective clinical utility of implementing a panel of PGx-markers into routine care, because the evidence base is currently limited to specific, individual drug-gene pairs. The Ubiquitous Pharmacogenomics Consortium (U-PGx), which has been funded by the European Commission’s Horizon-2020 programme, aims to address this unmet need. In a prospective, block-randomized, controlled clinical study (PREPARE), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which guidelines are available, will be implemented across healthcare institutions in seven European countries. The impact on patient outcomes and cost-effectiveness will be investigated. The program is unique in its multi-center, multi-gene, multi-drug, multi-ethnic, and multi-healthcare system approach.

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van der Wouden CH, Cambon-Thomsen A, Cecchin E, Cheung KC, Lucía Dávila-Fajardo C, Deneer VH, Dolžan V, Ingelman-Sundberg M, Jönsson S, Karlsson MO, Kriek M, Mitropoulou C, Patrinos GP, Pirmohamed M, Samwald M, Schaeffeler E, Schwab M, Steinberger D, Stingl J, Sunder-Plassmann G, Toffoli G, Turner RM, van Rhenen MH, Swen JJ, Guchelaar HJ; Ubiquitous Pharmacogenomics Consortium. Clin Pharmacol Ther. 2016 Dec 27. doi: 10.1002/cpt.602.